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EMA written submission needed
AB Science announces an update in the marketing authorization application of masitinib in amyotrophic lateral sclerosis at the European Medicines Agency A decision from the european medicines agency is expected… More >>
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Prilenia Announces Clinical Data in Support of its Plans to Initiate Global Phase 3 Study in ALS
Prilenia Therapeutics B.V., a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, will present clinical… More >>
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Ferrer Phase 3 ADORE trial with FAB122 (oral Edaravone) does not meet primary and secondary endpoints
Ferrer reports that Phase III ADORE clinical trial of oral edaravone formulation (FAB122) in amyotrophic lateral sclerosis (ALS) patients did not meet primary or key secondary endpoints. The ADORE clinical… More >>
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NeuroSense’s Phase 2b ALS Trial Achieves Primary Safety and Tolerability & Secondary Clinical Efficacy Endpoints
Top-Line Results from 6-month double-blind Phase 2b PARADIGM trial with NeuroSense’s lead drug candidate for ALS, PrimeC, include: NeuroSense Therapeutics, a company developing treatments for severe neurodegenerative diseases, reported that… More >>
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EMA CHMP negative opinion for AMX-0035 for treatment of ALS in EU upon re-examination
Amylyx Pharmaceuticals Receives Negative CHMP Opinion on its Marketing Authorisation Application for AMX0035 for the Treatment of ALS in the European Union Following Re-Examination Process CAMBRIDGE, Mass.– Amylyx Phammaceuticals. Inc.… More >>
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BrainStorm update on FDA review NurOwn for treatment of ALS
BrainStorm Cell Therapeutics Provides Update on FDA Advisory Committee Meeting to Review NurOwn for the Treatment of ALS BrainStorm Cell Therapeutics, a leading developer of adult stem cell therapeutics for… More >>
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ALS EU Coalition
EUpALS is partner of the #EUALSCoalition. On September 7 2023, 10 policy recommendations to improve ALS diagnosis, care and treatment were unveiled at an event in the European Parliament Brussels.… More >>
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Amylyx Pharmaceuticals Receives CHMP Negative Opinion on its Conditional Marketing Authorisation Application for AMX0035 for the Treatment of ALS in the European Union
Amylyx will seek re-examination of its Conditional Marketing Authorisation Application Amylyx announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted… More >>

